Endoscopic cryo-ablation company CSA Medical said today it won FDA 510(k) clearance for a 3rd spray kit, the rapid AV spray kit, for its TruFreeze system.
The Boston-based company’s TruFreeze system is designed as a cryosurgical tool designed for use in dermatology, gynecology, general surgery and to ablate benign and malignant lesions. The newly cleared addition is designed to shorten the time to liquid nitrogen spray by 50%, the company said.
The company touted the TruFreeze device as the only ablation technology designed to ablate Barrett’s Esophagus with a high grade dysplasia or cancers as such as in the esophagus with a non-contact liquid nitrogen spray cryotherapy system.
“We are pleased to have obtained FDA clearance to expand our product offerings for our TruFreeze system. With the addition of the Rapid AV spray kit, it is anticipated that physicians will be able to substantially reduce treatment times such that patients have a shorter procedural time,” prez & CEO Dr. Ellen Sheets said in a press release.